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MINIMS POVIDONE IODINE 5% W/V EYE DROPS SOLUTION

Active substance(s): POVIDONE-IODINE

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Art. 76920
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Nazwa produktu
Product Name

Minims Povidone Iodine
5% w/v
DRP SOL 20 single dose
units

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76920

Kod farmaceutyczny
Pharmacode

160 x 240 mm

Minims® Povidone Iodine 5% w/v Eye Drops, Solution
Iodinated Povidone

Black

Opracowane przez
Designed by
Nr korekty
Proof No

5

Data
Date

19.05.2016

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

P1UKIE01

Nobel BL Font family

Gramatura papieru
Paper weight

60 g/m2

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor or your pharmacist.
–– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Minims Povidone Iodine is and what it is used for
2. What you need to know before you use Minims Povidone Iodine
3. How to use Minims Povidone Iodine
4. Possible side effects
5. How to store Minims Povidone Iodine
6. Contents of the pack and other information
1. WHAT MINIMS POVIDONE IODINE IS AND WHAT IT IS USED FOR

Komentarze Comments (Reason for the change)
national registration of text folllowing - Safety variation and QRD update
PMR_ICN-15-1289-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

Minims Povidone Iodine is a solution that contains an antiseptic known as Iodinated Povidone in an eye wash solution.
It is used for cleaning the surface of your eye before eye surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS POVIDONE IODINE
Do not use Minims Povidone Iodine
–– if you are allergic to Iodinated Povidone, iodine or any of the other ingredients (listed in section 6)
–– for injecting into the eye
–– for any purpose other than cleaning the surface of your eye before eye surgery
–– at the same time as using medicines for use on the eye that contain mercury-based preservatives
–– in premature babies
Warnings and precautions
This product is strictly only for use to clean the eyes before surgery and should not be used for any other purpose.
Using other medicines
Talk to your doctor or pharmacist if you are:
–– applying any other medicines to your eyes especially antimicrobial eye drops and eye drops containing mercury-based preservatives, as these
may affect the way Minims Povidone Iodine works.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Pregnancy and breast-feeding
You can use this product if you are pregnant or if you are breast-feeding.
Driving and using machines
Minims Povidone Iodine is not meant for use outside the hospital or clinic and does not affect your ability to drive or use machines.
Minims Povidone Iodine contains disodium phosphate anhydrous
3. HOW TO USE MINIMS POVIDONE IODINE
Use in Adults
The drops are supplied in single-dose units that are meant to treat both eyes if both eyes are affected.
The recommended dose is two to three drops of the solution instilled onto the eye/eyes and leave for two minutes.
Use in children and adolescents
This product can be used in babies, infants, children and adolescents. The recommended dose is the same as for adults.
Instructions for proper use:
In the operating room and after the anaesthetic has been applied to your eyes, the nurse or doctor will clean your eyes with
Minims Povidone Iodine as follows:
1. The area around your eyes will be carefully cleaned with a sterile cotton swab.
2. The nurse / doctor will then twist off the cap of the Minims Povidone Iodine unit to open it.
3. Two to three drops of the solution will be gently dropped onto your eye/eyes.
4. You will be asked to close your eyes and roll your eyes around to spread the solution over the surface of the eyes.
5. The drops will be left on the eye / eyes for two minutes before rinsing. Your eyes will then be rinsed thoroughly with a sterile saline solution until the
characteristic colour of the Iodinated Povidone disappears.

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Art. 76920

P1UKIE01

4. POSSIBLE SIDE EFFECTS
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Nazwa produktu
Product Name

Minims Povidone Iodine
5% w/v
DRP SOL 20 single dose
units

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76920

Kod farmaceutyczny
Pharmacode

-

P1UKIE01

Inny kod
Other code

-

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Black

Opracowane przez
Designed by
Nr korekty
Proof No
Kod wersji
Valeant version code
Rozmiar czcionki
Font size
Krój czcionki
Font used

5

Data
Date

19.05.2016

Nobel BL Font family

Gramatura papieru
Paper weight

60 g/m2

Komentarze Comments (Reason for the change)
national registration of text folllowing - Safety variation and QRD update
PMR_ICN-15-1289-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with either iodine or povidone in published literature and could be associated with the use
of Minims Povidone Iodine.
Rare (may affect up to 1 in 1,000 people)
–– Eyes that are red, superficial inflammation of the cornea (transparent membrane of the eye).
Very rare (may affect up to 1 in 10,000 people)
–– allergic and pseudo-allergic reactions, such as red and itchy rash, swelling of the face, hands and feet, eyes, lips and/ or tongue, difficulties in
breathing or swallowing, low blood pressure; some of them may be life-threatening.
–– In very rare cases, some patients with severe damage to the clear layer at the front of the eye(the cornea) have developed cloudy patches on the
cornea due to calcium build-up during treatment.
Not known (frequency cannot be estimated from the available data)
–– yellowing of the eyes; irritant effect on mucosa (membrane that lines various cavities in the body) and deep tissue; reversible, transient brown
coloration (which can the removed with water).
Use in children
Not known (frequency cannot be estimated from the available data)
In neonates Minims Povidone Iodine may have an effect on the thyroid, causing the thyroid gland to not make enough thyroid hormones to meet the
body's needs.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via:
United Kingdom
Ireland
Yellow Card Scheme
HPRA Pharmacovigilance
Website: www.mhra.gov.uk/yellowcard
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MINIMS POVIDONE IODINE
Keep this medicine out of the reach and sight of children.
For single use only. Discard immediately after first use.
Do not use this medicine after the expiry date which is stated on the overwrap of each unit and on the carton after the letters “EXP”. The expiry date
refers to the last day of that month.
Store between 2°C and 8°C.
Store in the original package to protect from light.
This medicine can be stored unrefrigerated below 25°C for up to one month. After this period the product should be discarded. When you take it out of
the refrigerator, write the current date on the carton, as well as the date for a month later, so that you know when to discard the medicine.
Do not use Minims Povidone Iodine if you notice that the container is damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Minims Povidone Iodine contains
–– The active substance is Iodinated Povidone. Each single-dose container contains 20 mg of Iodinated Povidone in 0.4 ml of solution. One ml
solution contains 50 mg Iodinated Povidone.
–– The other ingredients are glycerol, nonoxinol 9, disodium phosphate anhydrous, citric acid monohydrate, sodium chloride, sodium hydroxide and purified water.
What Minims Povidone Iodine looks like and contents of the pack
This medicinal product is a presented as eye drop solution in single-dose container marked with “PVI 5.0”.
This solution is a deep brown-red coloured solution.
Each single-dose container is overwrapped in a plastic sachet. Each carton contains 20 single-dose containers.
Marketing Authorisation Holder and Manufacturer
Manufacturer:
Marketing Authorisation Holder:
Laboratoire Chauvin
Bausch & Lomb U.K. Ltd
Z.I.Ripotier Haut
106 London Road
07200 Aubenas
Kingston-Upon-Thames
France
Surrey, KT2 6TN
This leaflet was last revised in April 2016.
Minims is a trademark of Bausch & Lomb Incorporated or its affiliates. © Bausch & Lomb Incorporated
--------------------------------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare
Using a suitable syringe, irrigate the eye / eyes thoroughly with sterile
professionals only:
saline 0.9% w/v solution until the characteristic colour of the iodine
Posology
solution disappears
Adults (including the elderly)
Contraindications
–– Hypersensitivity to iodinated povidone, to iodine or to any of the
Instill two to three drops of the solution onto the eye / eyes and leave for
two minutes.
medicinal product’s excipients
Paediatric population
–– Minims Povidone Iodine 5% w/v eye drops, solution is
The adult dose may be used in neonates, infants, children and
contraindicated for intra-ocular or peri-ocular injection
–– Concomitant use with topical ophthalmic formulations containing
adolescents
mercury-based preservatives
Method of administration:
–– Wash hands thoroughly before use
–– Pre-term neonates
–– Clean the area around the eyes with a sterile cotton swab
Special precautions for storage
–– Twist off the cap of the container to open it
The product may be stored without refrigeration at not more than 25°C
–– Do not touch the eye with the single-dose container nozzle
for up to one month. Where needed, the adhesive label provided in the
–– Gently instill 2 to 3 drops of the solution onto the eye / eyes
carton may be completed and affixed in the area provided on the carton
by a pharmacist, indicating an expiry date of one month from the date of
–– Allow the solution to spread, by asking the patient to close their eyes
supply, date of removal from refrigerator, new expiry date and discard
and roll their eyes around
–– Leave the drops on the eye / eyes for two minutes before rinsing:
immediately after first use.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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